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The thoughtful article "The Icelandic database - do modern times need
modern sagas?" misrepresents two key features of the database, and the
position of the Council of Europe Steering Committee on Bioethics.
First, in the discussion of consent, it is stated: "Icelanders have
been offered the opportunity to opt out of the database and will be
informed continuously about their right to withdraw from the database at
any time."
This assertion is misleading because once data are deposited in the
database, patients cannot withdraw from database research. Thus, by
participating, Icelanders are forced to relinquish the fundamental human
right to unconditionally withdraw at any time from research studies. While
this provision minimizes financial risk for deCODE's shareholders, it is
unethical and illogical because individuals should be able to make a more
"informed" decision about participation after seeing how the database
functions, rather than before it starts operation.
Second, it is incorrect to state: "Though the original bill allowed
for a decoding key, this was removed in the final version."
The decoding key was not removed in the final version of the bill; it
will be in continuous use and is required to add new data from medical
records, to correct mistakes, and to connect the dynamic health sector
database with genetic and genealogical databases. Had the decoding key
been removed, these functions could not be carried out.
In the final version of the bill, the encryption was made more
elaborate and specifically it was made harder - although by no means
difficult - to use the decoding key to identify an individual based on a
data set (referred to as one-way coding).
Finally, the article incorrectly reports that the Council of Europe
Steering Committee on Bioethics concluded that the database was anonymous.
The citation for this statement is the position of the Icelandic
government, as reported to the Council of Europe, and not that of the
Steering Committee. As an indication of the highly incestuous relationship
between deCODE and the Icelandic government, this report is largely a
translation of a legal opinion solicited by deCODE in the fall of 1998.
To justify the use of presumed consent, deCODE and the Icelandic
government wrongly assert that the database is anonymous. This is a
fundamental flaw in the legislation and an infraction of European
conventions and agreements on data protection. In addition, an exclusive
license to construct and run a health sector database runs counter to EFTA
antitrust regulations. Steps have been taken to preserve civil liberties
in Iceland, and to ensure that our health data, including genetic
information, will be used to facilitate scientific discoveries and not
"locked in" a monopoly. As these cases wind their way through the
European courts, deCODE's shareholders may indeed discover that the
database idea poses more than minimum risk.
Bogi Andersen, assistant professor of medicine, University of
California, San Diego
Einar Arnason, professor of evolutionary biology and population genetics,
University of Iceland
Skuli Sigurdsson, historian of science and technology, Humboldt
University, Berlin
KAFKAESQUE ETHICS FOR POST-MODERN VIKINGS?
The thoughtful article "The Icelandic database - do modern times need
modern sagas?" misrepresents two key features of the database, and the
position of the Council of Europe Steering Committee on Bioethics.
First, in the discussion of consent, it is stated: "Icelanders have
been offered the opportunity to opt out of the database and will be
informed continuously about their right to withdraw from the database at
any time."
This assertion is misleading because once data are deposited in the
database, patients cannot withdraw from database research. Thus, by
participating, Icelanders are forced to relinquish the fundamental human
right to unconditionally withdraw at any time from research studies. While
this provision minimizes financial risk for deCODE's shareholders, it is
unethical and illogical because individuals should be able to make a more
"informed" decision about participation after seeing how the database
functions, rather than before it starts operation.
Second, it is incorrect to state: "Though the original bill allowed
for a decoding key, this was removed in the final version."
The decoding key was not removed in the final version of the bill; it
will be in continuous use and is required to add new data from medical
records, to correct mistakes, and to connect the dynamic health sector
database with genetic and genealogical databases. Had the decoding key
been removed, these functions could not be carried out.
In the final version of the bill, the encryption was made more
elaborate and specifically it was made harder - although by no means
difficult - to use the decoding key to identify an individual based on a
data set (referred to as one-way coding).
Finally, the article incorrectly reports that the Council of Europe
Steering Committee on Bioethics concluded that the database was anonymous.
The citation for this statement is the position of the Icelandic
government, as reported to the Council of Europe, and not that of the
Steering Committee. As an indication of the highly incestuous relationship
between deCODE and the Icelandic government, this report is largely a
translation of a legal opinion solicited by deCODE in the fall of 1998.
To justify the use of presumed consent, deCODE and the Icelandic
government wrongly assert that the database is anonymous. This is a
fundamental flaw in the legislation and an infraction of European
conventions and agreements on data protection. In addition, an exclusive
license to construct and run a health sector database runs counter to EFTA
antitrust regulations. Steps have been taken to preserve civil liberties
in Iceland, and to ensure that our health data, including genetic
information, will be used to facilitate scientific discoveries and not
"locked in" a monopoly. As these cases wind their way through the
European courts, deCODE's shareholders may indeed discover that the
database idea poses more than minimum risk.
Bogi Andersen, assistant professor of medicine, University of
California, San Diego
Einar Arnason, professor of evolutionary biology and population genetics,
University of Iceland
Skuli Sigurdsson, historian of science and technology, Humboldt
University, Berlin
Competing interests: No competing interests